Effects of Paresthesia Free Spinal Cord Stimulation on Pain Intensity, Functional Improvement, Pain Thresholds and Sensory Perceptions in Chronic Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 20% increase of NRS (numerical rating scale) pain scale
研究概览
简要总结
The goal is to document efficacy of PF-SCS therapy in a blinded fashion and better understand how SCS therapy works in the clinical setting. Overall the investigators hope to improve patient care and selection of candidates who have the best potential for effective pain relief from an expensive and invasive therapy.
详细描述
The PF-SCS has 3 programs (P1, P2, P3) that can be used. At Visit 1, the study physician will review the PF-SCS program that the participant has been using. This program is known as the optimal program (OPP) and will be known as P1. The study physician will then designate the other two programs (P2 and P3); one of them will be identical to the OPP (P1) and the other program will be the LAP. The participant will be unaware if the LAP is assigned to P2 or P3. At the end of Visit 1, the study physician will have the participant switch from P1 to the LAP (P2 or P3). The participant will be reassured that if their pain returns after they switch programs, they can immediately call the study physician and will be switched back to the previous OPP (P1) without delay. The participants whose pain returns will be categorized as Group 1. The physician will document the time that had elapsed before their pain returned. This time will be considered as "carry over time" (COT) from PF-SCS. Only the study physicians will be aware of the programming parameters for P2 and P3. The rest of the study staff and participants will be blinded and will not be aware of the programming parameters for P2 and P3.
The participants whose pain remains stable while on the LAP will be categorized as Group 2. All participants will keep a daily diary for pain intensity, sleep and any other concerns that may arise related to the change of program.
At the end of Visit 1, a member of the study team will schedule Visit 2, between 14 to 28 days from Visit 1.
Phone call: A study physician will call subjects between 7-14 days after Visit 1. Group 1 participants will be asked to switch to the LAP (P2 or P3) before Visit 2. To minimize the duration of the LAP, Visit 2 will be scheduled within six hours from the end of COT. The Group 2 participants will attend Visit 2 without changing their LAP.
At Visit 2, participants will fill out questionnaires on pain intensity, sleep, activities and global impression. A blinded study staff will perform QST on the subject. At the end of Visit 2, Group 1 participants will be instructed to go back to the OPP (P1). At the end of Visit 2, Group 2 will be allowed to switch back to the OPP (P1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The participant and study staff will be blinded. The study physicians will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject will be 18-80 years old
- •Subject who is currently treated with PF-SCS (HF-10 or Burst-mode capable SCS system) for chronic pain
排除标准
- •Subject has neurological disease or a condition causing chronic persistent sensory deficit to the painful area
- •Those receiving remuneration for their pain treatment (pending litigation or ongoing litigation).
- •Those unable to read English and complete the assessment instruments.
研究组 & 干预措施
Pain Returns
PF-SCS programming: in a blinded fashion, subjects will be asked to switch to the lowest amplitude program (LAP). Subjects whose pain returns after switching to the LAP will be considered Group 1.
干预措施: PF-SCS programming (Device)
No Pain
PF-SCS programming: in a blinded fashion, subjects will be asked to switch to the lowest amplitude program (LAP). Subjects whose pain does not return after switching to the LAP will be considered Group 2.
干预措施: PF-SCS programming (Device)
结局指标
主要结局
20% increase of NRS (numerical rating scale) pain scale
时间窗: from date of consent until end of study (14-28 days)
20% increase on low back pain NRS pain scale (0 = no pain and 10= maximum pain imaginable) while on LAP (lowest amplitude program) compared to OPP (optimal program).
次要结局
- Daily diary results(from date of consent until end of study (14-28 days))
- Quantitative Sensory Testing (QST) Results(from date of consent until end of study (14-28 days))
研究者
Shihab Ahmed, MD
Principal Investigator
Massachusetts General Hospital